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Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.
To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI201335 low dose Efavirenz | Experimental | low dose Efavirenz |
|
| BI201335 high dose Efavirenz | Experimental | normal dose Efavirenz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose | Drug | efavirenz single dosing once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Group A - Efavirenz: Cmax | Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz |
| Group A - Efavirenz: AUC0-∞ | Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz |
| Group B - Faldaprevir: Cmax,ss | Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
| Group B - Faldaprevir: AUC0-12h,ss | Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
| Group B - Faldaprevir: C12,ss | Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| Group A - Faldaprevir: Cmax,ss | Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
| Group A - Faldaprevir: Tmax,ss |
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Inclusion criteria:
Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.20.41001 Boehringer Ingelheim Investigational Site | Basel | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: 240 mg Faldaprevir+50 mg Efavirenz | Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19. Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14. oral administration with water after food intake. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| normal dose |
| Drug |
efavirenz once daily |
|
| low dose | Drug | Efavirenz single dosing once daily |
|
Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) |
| 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
| Group A - Faldaprevir: AUC0-12h,ss | Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
| Group A - Faldaprevir: C12,ss | Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
| Group A - Efavirenz: Tmax | Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz |
| Group B - Faldaprevir: Tmax,ss | Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
| Group B - Midazolam: Cmax | Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
| Group B - Midazolam: Tmax | Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
| Group B - Midazolam: AUC0-∞ | Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | From first treatment administration (Day 1) up to Day 24 |
| Group A - Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone. | From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24) |
| Group B - Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone. | From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24) |
| Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam |
Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18. Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18. oral administration with water after food intake. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: 240 mg Faldaprevir+50 mg Efavirenz | Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19. Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14. oral administration with water after food intake. |
| BG001 | Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam | Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18. Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18. oral administration with water after food intake. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Group A - Efavirenz: Cmax | Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz |
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| Primary | Group A - Efavirenz: AUC0-∞ | Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | all subjects entered in sequence group A of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz |
|
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| Primary | Group B - Faldaprevir: Cmax,ss | Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
|
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| Primary | Group B - Faldaprevir: AUC0-12h,ss | Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
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| Primary | Group B - Faldaprevir: C12,ss | Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir |
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| Secondary | Group A - Faldaprevir: Cmax,ss | Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | All patients entered in sequence group A of the PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
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| Secondary | Group A - Faldaprevir: Tmax,ss | Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | All patients entered in sequence sequence group A of the PK set | Posted | Median | Full Range | hours | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
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| Secondary | Group A - Faldaprevir: AUC0-12h,ss | Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | All patients entered in sequence group A of the PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
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| Secondary | Group A - Faldaprevir: C12,ss | Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | All patients entered in sequence group A of the PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
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| Secondary | Group A - Efavirenz: Tmax | Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz) | All patients entered in sequence group A of the PK set | Posted | Median | Full Range | hours | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz |
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| Secondary | Group B - Faldaprevir: Tmax,ss | Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | All patients entered in sequence group B of the PK set | Posted | Median | Full Range | hours | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir |
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| Secondary | Group B - Midazolam: Cmax | Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
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| Secondary | Group B - Midazolam: Tmax | Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Median | Full Range | hours | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
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| Secondary | Group B - Midazolam: AUC0-∞ | Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam) | all subjects entered in sequence group B of the PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam |
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| Secondary | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication | Posted | Number | participants | From first treatment administration (Day 1) up to Day 24 |
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| Secondary | Group A - Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone. | all subjects entered in sequence group A of the treated set. | Posted | Number | participants | From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24) |
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| Secondary | Group B - Number of Participants With Drug Related Adverse Events | Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment. AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone. | all subjects entered in sequence group B of the treated set. | Posted | Number | participants | From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24) |
|
From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Efavirenz | Treatment with single-dose Efavirenz in Group A. | 0 | 14 | 3 | 14 | ||
| EG001 | Group A: Faldaprevir | During treatment with Faldaprevir in Group A. | 0 | 14 | 13 | 14 | ||
| EG002 | Group A: Faldaprevir+Efavirenz | During treatment with Faldaprevir and single-dose Efavirenz in Group A. | 0 | 13 | 11 | 13 | ||
| EG003 | Group B: Midazolam | Treatment with single-dose Midazolam in Group B. | 0 | 15 | 1 | 15 | ||
| EG004 | Group B: Faldaprevir | During treatment with Faldaprevir in Group B. | 0 | 15 | 14 | 15 | ||
| EG005 | Group B: Faldaprevir+Midazolam | During treatment with Faldaprevir and single-dose Midazolam in Group B. | 0 | 15 | 6 | 15 | ||
| EG006 | Group B: Faldaprevir+Midazolam+Efavirenz | During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B. | 0 | 15 | 15 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 14.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Hypnagogic hallucination | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Circadian rhythm sleep disorder | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Ocular icterus | Eye disorders | MEDDRA 14.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MEDDRA 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Rash maculo?papular | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Rash vesicular | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Generalised erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | MEDDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 14.0 | Systematic Assessment |
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| Feeling hot | General disorders | MEDDRA 14.0 | Systematic Assessment |
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| Malaise | General disorders | MEDDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA 14.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MEDDRA 14.0 | Systematic Assessment |
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| Weight decreased | Investigations | MEDDRA 14.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
Not provided
Not provided
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| Participants |
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| OG004 | Total On-treatment | Total number of participants with drug related adverse events during treatment. |
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